MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05840-LWS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported " possible he loss 2 alarms.[the user] states they are happening every 2 minutes and has had 4 total.[the user] verified there is no blood in driveline and that all connections are tight.The md managing the patient is at bedside.Leak test showed iab positive for a leak".Additional information states the iab catheter was removed and not replaced.The patient was treated with other methods in lieu of iab therapy.
Event or Problem Description
It was reported "possible he loss 2 alarms.[the user] states they are happening every 2 minutes and has had 4 total.[the user] verified there is no blood in driveline and that all connections are tight.The md managing the patient is at bedside.Leak test showed iab positive for a leak".Additional information states the iab catheter was removed and not replaced.The patient was treated with other methods in lieu of iab therapy.The patient's current condition is reported as "critical".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint that the "leak test showed iab positive for a leak" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22828058
• Report Number: 3010532612-2025-00760
• Device Sequence Number: 4553118
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: (01)00801902007247(11)240724(17)260630(10)18F24G0053(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F24G0053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Race: Native Hawaiian Or Other Pacific Islander